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Pre- and Intra-operative Intravitreal Bevacizumab Injection in Diabetic Vitrectomy (IBDV)

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00745498
First received: September 2, 2008
Last updated: January 11, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.


Condition Intervention
Proliferative Diabetic Retinopathy
Vitrectomy
Drug: Bevacizumab

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Study of Pre- and Intra-operative Intravitreal Bevacizumab Injection on Postoperative Vitreous Hemorrhage After Diabetic Vitrectomy

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Recurrent VH incidence (early and late)and initial time of vitreous clearing (IVTC) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intraoperative bleeding incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Postoperative resolution of neovascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Visual outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preop IVB
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 7 days before vitrectomy
Drug: Bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)
Other Name: avastin
Experimental: Intraop IVB
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Drug: Bevacizumab
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)
Other Name: avastin
No Intervention: No IVB
Patients will not receive bevacizumab before nor during vitrectomy

Detailed Description:

Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade and preoperative bevacizumab injection. Bevacizumab(Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.Our hypothesis is that preoperative bevacizumab injection could reduce postoperative VH by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative VH by inhibiting the vessel formation after surgery.

To prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing first vitrectomy for complications of proliferative diabetic retinopathy such as vitreous hemorrhage, tractional fibrovascular membrane proliferation, tractional or combined retinal detachment)

Exclusion Criteria:

  • Follow-up period of less than 6 months
  • Repeat vitrectomy after first vitrectomy for diseases other than vitreous hemorrhage
  • Not first vitrectomy
  • Uncontrolled hypertension
  • Medical history of abnormal blood coagulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745498

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyunggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Kyu Hyung Park, M.D. Seoul National Univeristy Bundang Hospital
  More Information

Publications:
Responsible Party: Kyu Hyung Park, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00745498     History of Changes
Other Study ID Numbers: B-0801-053-004, B-0801-053-004
Study First Received: September 2, 2008
Last Updated: January 11, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
Proliferative diabetic retinopathy
vitrectomy
bevacizumab
vitreous hemorrhage

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Vitreous Hemorrhage
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Eye Hemorrhage
Hemorrhage
Pathologic Processes
Vascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014